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The BA will apply their extensive experience in GxP-compliant working environments and mastery of Computer System Validation (CSV) required to deliver regulated GMP IT products and capabilities. _
- Business Analysis capabilities
- Is an active part in the product's lifecycle management and ensures that any solution is chosen to fulfill known and understood business requirements, fitting into the Product roadmap definitions and continuously providing business value over its lifecycle.
- Often assumes the additional role of IT Business Partner, Product Manager, Squad Lead where appropriate
- Develops and maintains the business case including high level solution options and resource estimates and resource confirmation as in support to the strategic backlog management process
- Acts as an interface between business and IT functions and as a contact point for business leads in order to launch initiatives, leading and driving the scoping phase.
- Collaborates with IT Business Partner and/or Product Manager in business development activities like translating business strategy in technology enabled strategies, C-POD activities, portfolio management processes, feasibility studies, clarifying available technology on the market and vendor selection (RFI/RFP/RFQ)
- Strives for harmonization of business processes across sites and departments by propagating common standardized data models, applications and technologies that are in line with the cross-functional or functional Informatics strategies and architectures.
- Performs typical Business Analysis activities and creates deliverables as per Roche standards within a squad/project like a Business Case, Project Charter and URS/User Stories
- Works with delivery and the project team to ensure that the final solution matches the URS and customer's needs and is delivered according to plan
- Responsibilities specific to role:
- Create/develop detailed user requirements or agile user stories with acceptance criteria for drug product and drug substance template.
- Develop all validation/qualification and acceptance testing efforts, including SAT, UAT, and dry runs.
- Liaise with the different sites for micro-refinements and scale / retrofit to other sites.
- Manage the URS in terms of backlog, sprint, etc. Ensure simple and crisp language that is concise and targeted for the various different audiences e.g. differentiating PTM LT (CEC-2) vs. Operator on in IX.
- Effectively communicate with the IT development team and the extended project team.
- Independently make BA project decisions with impact at the process, organization, or program level.
- Having Roche experience is an Advantage.
- Life science industry experience.
- Experience in Product Lifecycle Management.
- Business Analysis experience in the GXP compliant environment.
- Working experience in the enterprise Setup.*
Job Types: Full-time, Permanent
Pay: RM8,
- 00 - RM15,000.00 per month
